This CMC Biopharma MasterClass 3.0 will provide a deep and detailed instruction on 91AV, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as illustration and proper time will be allowed for discussion designs and outcomes.
By the end of the MasterClass, the participants will understand:
• Process Development Strategies
• Analytical and Formulation Development
• GMP Manufacture
• Process Analytical Technology
• Guidelines and Regulatory Pathways for New Biological Entities and Biosimilars
By the end of the MasterClass, the participants will understand:
• Process Development Strategies
• Analytical and Formulation Development
• GMP Manufacture
• Process Analytical Technology
• Guidelines and Regulatory Pathways for New Biological Entities and Biosimilars
